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A Study in Healthy Men to Test How BI 1358894 is Taken up in the Body and How Food Influences the Amount of BI 1358894 in the Blood

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT04426851
Collaborator
(none)
12
Enrollment
1
Location
3
Arms
3
Actual Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main objective of Part 1 of this trial is to investigate the absolute bioavailability of BI 1358894 with an intravenous microdose formulation containing labelled [C-14] BI 1358894 and an unlabelled oral tablet formulation of BI 1358894 in healthy male subjects.

The main objective of Part 2 of this trial is to investigate the relative bioavailability of BI 1358894 administered as an oral suspension.

Condition or Disease Intervention/Treatment Phase
  • Drug: BI 1358894
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Part 1: non-randomized, fixed-sequence design Part 2: randomized, two-period, two-sequence, crossover designPart 1: non-randomized, fixed-sequence design Part 2: randomized, two-period, two-sequence, crossover design
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Investigation of Pharmacokinetics and Absolute Bioavailability of BI 1358894 Administered Orally as Tablet Co-administered With an Intravenous Microtracer Dose of [C-14]-BI 1358894 in Healthy Male Volunteers Via a Non-randomised, Open-label, Fixed-sequence Trial (Part 1) Followed by a Randomised, Open-label, Single-dose, Two-period, Two-sequence Cross-over Relative Bioavailability Trial in BI 1358894 Oral Suspension (Part 2)
Actual Study Start Date :
Jul 13, 2020
Actual Primary Completion Date :
Oct 12, 2020
Actual Study Completion Date :
Oct 12, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part 2: BI 1358894 (Test 2-Reference 2)

BI 1358894

Drug: BI 1358894
BI 1358894
Experimental: Part 2: BI 1358894 (Reference 2-Test 2)

BI 1358894

Drug: BI 1358894
BI 1358894
Experimental: Part 1: BI 1358894 (Test 1-Reference 1)

BI 1358894

Drug: BI 1358894
BI 1358894

Outcome Measures

Primary Outcome Measures

  1. Part 1: AUC 0-inf (area under the concentration-time curve of the analyte over the time interval from 0 to infinity after intravenous (iv) administration) for (C-14) BI 1358894 iv [Up to 14 days]

  2. Part 1: AUC 0-inf (area under the concentration-time curve of the analyte over the time interval from 0 to infinity after oral (po) administration) for BI 1358894 po [Up to 14 days]

  3. Part 2: AUC 0-312 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 312 h) [Up to 14 days]

Secondary Outcome Measures

  1. Part 1: Cmax (maximum measured concentration of the analyte after oral administration) [Up to 14 days]

  2. Part 2: Cmax (maximum measured concentration of the analyte after oral administration) [Up to 14 days]

  3. Part 2: AUC 0-inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity after oral administration) [Up to 14 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests

  • Age of 18 to 55 years (inclusive)

  • BMI of 18.5 to 29.9 kg/m2 (inclusive)

  • Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation

  • Male subjects who meet any of the following criteria from at least 30 days before the first administration of trial medication until 90 days after trial completion:

  • Use of adequate contraception of the female partner, e.g. any of the following methods plus condom: implants, injectables, combined oral or vaginal contraceptives, intrauterine device that started at least 2 months prior to first study drug administration or barrier method (e.g. diaphragm with spermicide) or,

  • Sexually abstinent or

  • A vasectomy performed at least 1 year prior to screening (with medical assessment of the surgical success) or

  • Surgically sterilised female partner (including hysterectomy, bilateral tubal occlusion or bilateral oophorectomy) or

  • Postmenopausal female partner, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with FSH (follicle stimulating hormone) above 40 U/L and estradiol below 30 ng/L is confirmatory)

Exclusion Criteria:

  • Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator

  • Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 40 to 100 bpm

  • C-reactive protein (CRP) > upper limit of normal (ULN), liver or kidney parameter above ULN

  • Any laboratory value outside the reference range that the investigator considers to be of clinical relevance

  • Any evidence of a concomitant disease assessed as clinically relevant by the investigator

  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

  • Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)

  • Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders

  • Further exclusion criteria apply

Contacts and Locations

Locations

Site City State Country Postal Code
1 PRA Health Sciences Onderzoekscentrum Martini Groningen Netherlands 9728 NZ

Sponsors and Collaborators

  • Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT04426851
Other Study ID Numbers:
  • 1402-0016
  • 2020-000351-13
First Posted:
Jun 11, 2020
Last Update Posted:
Oct 30, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 30, 2020